Safe and Timely Antithrombotic Removal (STAR) Registry

July 15, 2025 updated by: CytoSorbents, Inc

Safe and Timely Antithrombotic Removal (STAR) Registry: International Registry on the Use of CytoSorb for Removal of Antithrombotic Agents in the Acute Hospital Setting

This registry will capture real-world clinical use patterns and associated clinical outcomes with the use of CytoSorb for the removal of antithrombotic agents.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The STAR Registry will collect patient-level clinical data on antithrombotic removal with CytoSorb. The decision to use CytoSorb in this clinical setting is based on the clinical rationale of mitigating the high risk of bleeding events that is directly linked to the presence of the antithrombotic agent. This registry is to capture real-world clinical use patterns and associated clinical outcomes with the use of CytoSorb. Data of retrospective and prospective patients will be included in the registry. Safety will be assessed by collection of (at least possibly) device-related adverse events. Data collection is done up to 30 days post-operation.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Graz, Austria
        • Recruiting
        • Universitätsklinikum Graz
        • Principal Investigator:
          • Christian Mayer, MD
      • Innsbruck, Austria
        • Recruiting
        • Medizinische Universität Innsbruck
        • Principal Investigator:
          • Judith Martini, Univ.-Prof., PD, MD
      • Klagenfurt, Austria
        • Recruiting
        • Klinikum Klagenfurt am Wörthersee
        • Principal Investigator:
          • Markus Köstenberger, MD
      • Vienna, Austria
        • Recruiting
        • Medical University of Vienna
        • Principal Investigator:
          • Martin Bernardi, ap. Prof. PD Dr. Dr.
  • Belgium
      • Aalst, Belgium
        • Recruiting
        • OLV ziekenhuis Aalst VZW
        • Principal Investigator:
          • Nikolaas De Neve, MD
      • Bruxelles, Belgium
        • Recruiting
        • Cliniques Universitaires Saint-Luc
        • Principal Investigator:
          • Robert Tircoveanu, MD
      • Ghent, Belgium
        • Recruiting
        • University Hospital Ghent
        • Principal Investigator:
          • Filip de Somer, Prof, PhD
      • Liège, Belgium
        • Recruiting
        • Centre Hospitalier Universitaire de Liège
        • Principal Investigator:
          • Manuel Azevedo Mendes, MD
  • Germany
      • Coswig, Germany
        • Recruiting
        • Evangelisches Herzzentrum Coswig
        • Principal Investigator:
          • Thomas Eberle, MD
      • Erlangen, Germany
        • Recruiting
        • Herzchirurgische Klinik Erlangen
        • Principal Investigator:
          • Mathieu Suleiman, MD
      • Essen, Germany
        • Recruiting
        • Universitatsklinikum Essen
        • Principal Investigator:
          • Matthias Thielmann, Prof, MD
      • Hamburg, Germany
        • Recruiting
        • Asklepios Kliniken Hamburg GmbH
        • Principal Investigator:
          • Kambiz Hassan, MD
      • Hannover, Germany
        • Recruiting
        • Medizinische Hochschule Hannover
        • Principal Investigator:
          • Jan Schmitto, Prof, MD
      • Heidelberg, Germany
        • Recruiting
        • Universitätsklinikum Heidelberg - Klinik für Herzchirurgie
        • Principal Investigator:
          • Anna L. Meyer, Prof, MD
      • Kiel, Germany
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Herz- und Gefäßchirurgie
        • Principal Investigator:
          • Bernd Panholzer, MD
      • Leipzig, Germany
        • Recruiting
        • Herzzentrum Leipzig and Helios Health Institute GmbH Leipzig
        • Principal Investigator:
          • Michael Höbartner, MD
      • Munich, Germany
        • Recruiting
        • LMU Klinikum Großhadern
        • Principal Investigator:
          • Michael Schmoeckel, Prof, MD
      • Munich, Germany
        • Recruiting
        • Artemed Klinikum München Süd GmbH & Co. KG
        • Principal Investigator:
          • Helmut Mair, MD
      • München, Germany
        • Recruiting
        • Deutsches Herzzentrum München
        • Principal Investigator:
          • Keti Vitanova, PD, MD
      • Nürnberg, Germany
        • Recruiting
        • Klinikum Nürnberg
        • Principal Investigator:
          • Spela Leiler, MD
      • Oldenburg, Germany
        • Recruiting
        • Klinikum Oldenburg AöR
        • Principal Investigator:
          • Mareike Diekmann, MD
      • Trier, Germany
        • Recruiting
        • Krankenhaus der Barmherzigen Brüder Trier
        • Principal Investigator:
          • Terrence John Donovan, MD
      • Ulm, Germany
        • Recruiting
        • Universitatsklinikum Ulm
        • Principal Investigator:
          • Andreas Liebold, Prof, MD
  • Sweden
      • Lund, Sweden
        • Recruiting
        • Skane University Hospital Lund
        • Principal Investigator:
          • Sandra Lindstedt, MD, PhD
  • Switzerland
      • Geneva, Switzerland
        • Recruiting
        • Hôpitaux Universitaires Genève
        • Principal Investigator:
          • Vitor Nogueira Mendes
      • Zürich, Switzerland
        • Recruiting
        • Universitatsspital Zurich
        • Principal Investigator:
          • Hector Rodriguez Cetina Biefer, PD, MD
      • Zürich, Switzerland, 8063
        • Recruiting
        • Stadtspital Zürich Clinic for Cardiac Surgery
        • Principal Investigator:
          • Omer Dzemali, Prof., MD, Dr. h.c.
  • United Kingdom
      • Blackpool, United Kingdom
        • Recruiting
        • Blackpool Teaching Hospitals NHS Foundation Trust/ Blackpool Victoria Hospital
        • Principal Investigator:
          • Yvonne Ashworth
      • London, United Kingdom
        • Recruiting
        • Royal Brompton & Harefield Clinical Group (part of Guy's and St Thomas' NHS Foundation TRUST)
        • Principal Investigator:
          • Nandor Marczin, MD
      • Sheffield, United Kingdom
        • Recruiting
        • Sheffield Teaching Hospitals NHS Foundation Trust
        • Principal Investigator:
          • Steven Hunter, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing invasive management, including surgery, who receive CytoSorb therapy for antithrombotic removal as part of their routine clinical care can be included in this registry

Description

Inclusion Criteria:

  • CytoSorb utilization for antithrombotic removal
  • Informed consent for prospective registry participation

Exclusion Criteria:

• Use of CytoSorb for purpose other than antithrombotic removal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bleeding complications including requirements for transfusions and other blood products
Time Frame: Assessed until postoperative day (POD) 3, date of ICU discharge, or date of death, whatever comes first; on average 3 days
Assessed until postoperative day (POD) 3, date of ICU discharge, or date of death, whatever comes first; on average 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CytoSorbents, Inc

Investigators

  • Principal Investigator: Robert Storey, Prof, BSc, University of Sheffield
  • Principal Investigator: Michael Schmoeckel, Prof, MD, LMU Klinikum Großhadern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2021

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

September 9, 2021

First Submitted That Met QC Criteria

September 30, 2021

First Posted (Actual)

October 14, 2021

Study Record Updates

Last Update Posted (Actual)

July 16, 2025

Last Update Submitted That Met QC Criteria

July 15, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • O05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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